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The Pastelle laser system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

• Tattoo removal: dark ink (black, blue, and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma

1064nm in Genesis (long-pulse) mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):

• Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of Lentigines
• Treatment of Café-au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyperpigmentation
• Treatment of Becker's Nevi, Freckles, and Nevi spilus

The Pastelle laser system consists of an Nd:YAG laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains two Nd:YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed ,in the special adjustable holders composed the laser cavity.

The provided text is a 510(k) clearance letter and summary for the Pastelle Laser System. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, the document explicitly states: "No clinical studies were considered necessary and performed." This means there is no section describing clinical performance data, acceptance criteria, sample sizes for test/training sets, expert involvement, or ground truth establishment for clinical efficacy.

The "Performance Testing" section under "Non-Clinical Test Summary" describes the technical specifications of the laser's output, not clinical performance or acceptance criteria related to treating conditions. These are technical parameters of the device itself, verified through bench tests, not measures of patient outcomes.

Therefore, since the 510(k) relies on substantial equivalence to predicate devices and states no clinical studies were performed, there is no information available in the provided text to describe acceptance criteria and the study that proves the device meets those acceptance criteria in a clinical context.

The document focuses on demonstrating that the new Pastelle device is technically similar to already cleared predicate devices, thus inferring that it will perform similarly.

Based on the provided text, the device's acceptance criteria and proven performance related to clinical outcomes cannot be detailed. The data provided pertains to technical specifications and regulatory compliance through bench testing.

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